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. 2023 Feb 2;18(2):e0281300. doi: 10.1371/journal.pone.0281300

Lung deflation while placing a subclavian vein catheter: Our experience in minimizing the risk of pneumothorax

Daher K Rabadi 1,*, Ahmad K Abubaker 1, Sami A Almasarweh 2
Editor: Eyüp Serhat Çalık3
PMCID: PMC9894405  PMID: 36730282

Abstract

Purpose

Lung deflation may reduce the risk of pneumothorax based on the assumption that the distance between the subclavian vein and the lung pleura would increase as well as the diameter of the vein. We aim to provide evidence to support the suggested desideratum of deflation in adults.

Methods

A prospective database was created that included patients who underwent subclavian vein catheterization for monitoring and therapeutic reasons from January 2014 to January 2020. Measurements using ultrasonography of the diameter of the subclavian vein were taken while the patient’s breathing was controlled by a ventilator and then repeated after disconnecting the mechanical ventilation and opening the pressure relief valve.

Results

A total of 123 patients were enrolled, with an average age of 41.9 years. The subclavian vein diameter was measured during controlled breathing with a mean average of 8.1 ± 0.6mm in males and 7.1 ± 0.5mm in females. The average increase after lung deflation with the pressure relief valve closed was 8.0± 5.1mm in males and 13.9 ± 5.4mm in females. An increase was noticed after opening a pressure valve, and the means were 5.5 ± 2.8mm in males and 5.1 ± 3.3mm in females. The catheter malposition rate was 0.8%

Conclusion

The benefit of interrupting mechanical ventilation and lung deflation lies within possibly avoiding pneumothorax as a complication of subclavian vein catheterization. These findings support the need for evidence regarding the curtailment of pneumothorax incidence in spontaneously breathing patients and the suggested increase in first-time punctures and success rates.

Introduction

Central venous catheters are imperative in the modern era of medical practice. Defined as a catheter insertion in a great venous vessel, commonly placed in the internal jugular vein or subclavian vein to have the catheter end in the superior or inferior vena cava or the right atrium [1,2]. Nearly 8% of hospitalized patients have a central venous catheter and access site [3].

The Seldinger technique exhibits precedence in the choice of physicians. To mitigate the risk of complications, the utilization of ultrasound guidance in visualizing the vessel has been proven to increase the success rate of the aforementioned procedure [4]. Cannulating the subclavian vein is part of common medical practice and offers particular advantages when compared to other access sites. In comparison to other venous access points, patients who had subclavian catheters experienced fewer infectious complications [3,5]. Moreover, the access provided allows for the risk of a thrombotic event to be lower compared to other vein accesses and the ability to sustain patency in hypovolemic patients to be improved, along with better patient comfort and nursing care [68].

The advantages of the subclavian vein catheters is being more accessible to the operator in trauma patients, and it can be placed without disrupting the airway management during the initiatory phases of resuscitation. Failure rates vary depending on the physician’s experience, patient’s conditions, and clinical settings; nonetheless, complications can be avoided using proper techniques [9,10]. Prompt complications of such procedure include subclavian artery puncture, pneumothorax, hemothorax, chylothorax, mediastinal hematoma, and possible injury to the phrenic nerve [11,12].

The use of the subclavian vein may have its benefits compared to other large veins; however, the possibility of leading to pneumothorax is significant. The distance between the subclavian vein and the lung pleura is vital in reducing this possibility [13]. The proximity of the lung pleura to the vein varies with breathing. During full expiration, the lung volume will be decreased, maximizing the distance between the vein and pleura, thereby, in theory reducing the risk of pneumothorax. Furthermore, the effect of inspiration on the collapsibility of the vein can negatively affect the success rate of the catheter placement. The increase of the intrathoracic pressure during full expiration and the lung deflation can increase blood volume in the subclavian vein, making it more accessible when combined with the increase in space between the pleural and the aforesaid vein [14]. Mechanical ventilation is halted to prevent injury to adjacent structures during the procedure and prevent procedural lung injury [15]. Clinicians have used such a technique at their own discretion without clear evidence regarding its benefit. Despite the fact that this may increase the safety margin of the procedure, deflating the lung may cause hypoxemia in patients, and the occurrence of pneumothorax would not be wholly eliminated [7,16].

In this study, we aim to study the effect of lung deflation in previously spontaneously breathing adults who are being ventilated through intermittent mandatory ventilation during subclavian vein catheterization with respect to the diameter of the subclavian vein. This study also takes into consideration the rate of complications concerning apnea induced by disconnecting the ventilation machine and the catheterization procedure.

Methodology

A database was prospectively that included patients who underwent subclavian catheterization for monitoring and therapeutic causes between January 2014 and January 2020 at King Abdullah University Hospital (KAUH), a tertiary hospital affiliated with the Jordan University of Science and Technology (JUST). The database included adult patients that were operated on electively, excluding patients with infections at the puncture site, pregnant women, children, and patients who have congenital malformations. The patients enrolled had a central line placed in the subclavian vein which was performed by the most senior anesthesia consultant at KAUH, located in the north of Jordan. All the patients consented verbally and signed a written consent witnessed by the senior anesthesia consultant, escorting close family relative and the senior responsible nurse according to KAUH ethical protocol.

Approach

All the patients who were scheduled for surgery were instructed to follow the fasting protocol according to their care team. Upon arrival to the operating suite, a noninvasive arterial blood pressure monitor, and a pulse oximeter are attached for monitoring, and an electrocardiogram is done. After general anesthesia is induced, mechanical ventilation is initiated, and the respiratory rate is adjusted to maintain end-tidal CO2 of approximately 40mmHg. The anesthesia machine used was GE Datex Ohmeda Avance S5 (Datex-Ohmeda, Ohmeda Drive, Madison, Wisconsin, USA). An initial tidal volume of 6–8 ml/kg is used, and the positive end-expiratory pressure is calculated based on the patient’s bodyweight and set in mbar.

The patients were placed supine on a horizontal table with their heads in the midline position with arms adducted next to them. The arm corresponding to the site of the procedure is extended at the shoulder level to increase the distance between the clavicle and subclavian vein. After proper sterilization and draping of the area, including the neck and chest above the nipple line. 100% oxygen flow with inhaled anesthetic is used to maintain anesthesia and preoxygenation of the patient. After 1 minute, the patients were safely placed in the Trendelenburg position. The ultrasound probe would be placed parallel to the clavicle superiorly with slight acute angulation towards the sternum, offering a coronal view (Fig 1).

Fig 1. Position of ultrasound probe on the patient.

Fig 1

If the patient is a female, an assistant will apply pressure to the right breast tissue pulling it caudally to avoid having the tissue infiltrate the sterile field. The positive end-expiratory pressure is then stopped inducing apnea, and after 3 seconds, the ultrasound probe is placed in the same position previously mentioned. The patient is then reoxygenated for a short moment, and then with mechanical ventilation stopped, we opened the pressure relief valve, causing equivalency between the pressure within the pleural compartment and atmospheric pressure.

The ultrasound probe would remain at the same place during the intervention. The measurements were recorded manually and noted in a database without recording any personal or identifying details of the patients. The puncture was usually performed on the right side unless when there were any contraindications such as the presence of port catheters, axillary dissections, or ipsilateral shunts). Under sterile conditions, the puncture was performed using the Selinger technique. A 20cm long three-lumen catheter with a 0.32-inch diameter spring-wire guide is soft on one end and a "J" tip on the other (Arrow International LLC, Morrisville, North Carolina, USA). The needle was inserted at the junction between the lateral third of the length of the clavicle and the medial two-thirds. Correct catheter position was verified by ultrasound and steady flow of dark blood with pressure transduction.

Postprocedural protocol

Post-procedural complications were defined as pneumothorax, hemothorax, arterial puncture, missed puncture, subcutaneous hematoma, site infection, catheter malposition, chylothorax, air embolism, cardiac arrest. In addition, a postoperative chest x-ray was performed between 6 and 8 hours to rule out pneumothorax.

Statistical analysis

A paired t-test was used to compare the mean difference of subclavian vein diameter after every step describe in the manuever. The statistical analysis was two-tailed, and the significance threshold was set at 0.05 or less. The IBM® SPSS® Statistics version 26 (IBM, Armonk, New York, United States) was used for statistical analysis, and the institutional review board approved the study before the data collection commenced.

Ethical statement

The Institutional Research Board (IRB) at King Abdullah University Hospital and Jordan University of Science and Technology approved this study (decision reference number: 15–2011). Data collected was kept strictly confidential and was only analyzed for the purpose of this study. All the patient have signed a consent form as part of standard procedures at King Abdullah University Hospital and Jordan University of Science and Technology.

Results

A total of 123 patients were enrolled in the database of patients who had elective surgery, a subclavian vein catheter placed by the same physician, and fit our inclusion criteria. The mean of the ages was 42.6 years old, with the lowest being 18 years old and the highest being 93 years old. The population had a male predominance as 54.5% of the patients were identified as males (67 patients) and 45.5% as females (56 patients). 23.6% of the population were patients who were older than 60 years old. The average body mass indexes for males and females were 26.1 ± 4.0, and 24 ± 3.8 kg/m2, respectively. Table 1: Demographic Data.

Table 1. Patient demographic data.

Number of Patient n (%)
Total Number of Patients 123 (100%)
Male 67 (54.5%)
Female 56 (45.5%)
Older than 60 years of age 29 (23.6%)
Measure Mean Standard deviation
Age 42.6 19.8
Body Mass Index
Male 26.1 4
Female 24 3.8

The subclavian vein diameter during controlled breathing was measured in males with a mean average of 8.1 ± 0.6mm and 7.1 ± 0.5mm in females. The exact measurements were repeated after stopping the ventilation but without opening the pressure relief valve with an average of 8.9 ± 0.3mm and 8.5 ± 0.4mm in males and females, respectively. After opening the pressure relief valve, we observed a further increase in the diameter as the measurements were repeated while maintaining the same probe position in all patients; males and females were 9.4 ± 0.3mm and 8.9 ± 0.2mm, respectively. (Figs 2 and 3) There was no correlation between the increase in age and the changes in the diameter of the subclavian vein regardless of the state of the pressure valve. We noticed a statistically significant difference between the changes in diameter in males and females after disconnecting the mechanical ventilations and before opening the pressure relief valve. The mean change in females was 13.9 ± 5.4mm and 8.0± 5.1mm in males, with a p-value of 0.001(95% CI 12.44%-15.34%) and 0.001(95%CI 6.67%-9.24%) respectively.

Fig 2. Changes in diameter of the subclavian vein in female patients.

Fig 2

The green line represents the diameter of the subclavian vein when the patient is spontaneously breathing, the blue represents the diameter after causing lung deflation with pressure relief valve close and the yellow line is after opening the pressure relief valve. Each vertical line on the plot graph represents the diameter of the subclavian vein for each female patient therefore the distance between the cross-section point of the vertical line and the horizontal lines represents the difference in diameter per patient.

Fig 3. Changes in diameter of the subclavian vein in male patients.

Fig 3

The green line represents the diameter of the subclavian vein when the patient is spontaneously breathing, the blue represents the diameter after causing lung deflation with pressure relief valve close and the yellow line is after opening the pressure relief valve. Each vertical line on the plot graph represents the diameter of the subclavian vein for each male patient therefore the distance between the cross-section point of the vertical line and the horizontal lines represents the difference in diameter per patient.

The catheter malposition rate was 0.8% (1 patient), and no arterial punctures were observed. All the patients were attentively monitored for significant complications. There was no incidence of hemothorax or pneumothorax during the operations; however, one patient developed Pneumothorax four days postoperatively, and it was resolved immediately. The oxygen saturation level dropped momentarily below 95% in three patients (2.43%) during deflation who have been adequately ventilated afterward without any complications. All the patients were successfully weaned off of mechanical ventilation, and the average duration of hospital stay was five days.

Discussion

The risk of pneumothorax is substantially higher in subclavian venous catheterizations compared to the other sites, and it is one of the most common mechanical complications of the procedure.(6) It has been suggested that lung deflation may reduce the risk of pneumothorax based on the assumption that the distance between the subclavian vein and lung pleura would increase. However, there was an apparent lack of evidence to support the suggested desideratum of deflation in adults.

In this study, an increase was observed in the diameter of the subclavian vein in a considerable majority of our patients. (Fig 4) Lim et al. and Hightower et al., reported a similar increase in the subclavian vein cross-sectional area; however, their results were not statically significant [14,17]. Relating our findings to the risk of complications, the risk of pneumothorax compared to the literature is significantly lower [5,18,19]. Furthermore, previous studies evaluating mechanical ventilation and lung deflation did not perform the procedure under ultrasound guidance which has been proven to increase success rates compared to landmark-guided methods [13,16]. A study comparing continued and interrupted mechanical ventilation during the procedure confirms a low pneumothorax incidence when inducing apnea [20]. However, the aforementioned study performed the venipuncture with the pressure relief valve closed. In this study, the pressure relief valve was briefly opened after the end-expiration period and interruption of mechanical ventilation. Opening the valve allowed for the equivalency between the intrathoracic and atmospheric pressure to occur and increase the lung deflation, thereby increasing the diameter of the subclavian vein.

Fig 4. A- Ultrasound Image showing the subclavian vein diameter while the patient is mechanically ventilated.

Fig 4

B- the same plane showing the subclavian vein diameter while the patient is off mechanical ventilated and lung deflation is initiated. C- the subclavian vein diameter after opening the pressure release valve.

This study has not previously highlighted an added benefit to lung deflation. Compared to spontaneously breathing patients, lung deflation prevented the movement of organs within the thoracic cavity and chest wall. This facilitates having a more stable reference line while performing this procedure and reduces the risk of penetrating injury to adjacent structures. In addition, ventilation was resumed after the guidewire was securely inserted, not after placing the catheter. This slight alteration was implemented to ensure patients’ safety and avoid hypoxia.

Limitations

This study has its strengths and limitations. All the patients in our database had a subclavian vein placed by the same senior anesthetist who has placed over countless central lines in his career. This is to make sure that our complications and success rates are not affected by the lack of experience of the practitioner performing the procedure. The percentages of male and female patients are also relatively similar as there are gender-related anatomical differences or predisposing risk factors. One of the limitations of this study is the quality of plane ultrasound images provided and the lack of experience of the responsible team in the surgical suite using the ultrasonography machine for subclavian vein catheterization. This would negatively affect the possibility of standardizing the measurement procedure for the subclavian vein caliber as the operators hands would move during canulation. All the venipunctures were approached in the infraclavicular plane, and the supraclavicular approach was not considered. The database was created after the data collection phase ended, and it excluded patients that were critically ill and were exposed to high PEEP ventilation. Another limitation would be that the majority of the patients did not repeat the chest x-ray when discharged, and the possibility of detecting late-onset pneumothorax was not possible. The sample size is relatively small and increases the possibility of type II error during our analysis of our findings. Our study and findings warrant further assessments of apnea induction during central line placement in the subclavian vein, especially in critically ill patients. Further developments in evidence add to the technique’s superiority in terms of success rates and pneumothorax incidence and thereby promote the installation of guidelines ensuring patient safety and well-being. This is study is also highlighting the importance of standardizing vascular access protocols to include ultrasound guidance with advanced procedural maneuvers to improve its effectiveness in terms of clinical outcomes [21,22].

Conclusion

The benefit of interrupting mechanical ventilation and lung deflation lies within conceivably avoiding pneumothorax as a complication of subclavian vein catheterization. The findings within this study support the need for evidence regarding support the curtailment of pneumothorax incidence and the suggested increase in first-time punctures and success rates in healthy, spontaneously breathing patients.

Data Availability

The dataset is not available publicly according to Institutional Review Board (IRB) decision (decision reference number: 15-2011) however it can accessed after obtaining the approval of the ethics committee at King Abdullah University Hospital and Jordan University of Science & Technology by contacting the following email: IRB@just.edu.jo.

Funding Statement

The author(s) received no specific funding for this work.

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Decision Letter 0

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1 Sep 2022

PONE-D-22-12796Lung Deflation while Placing a Subclavian Vein Catheter: Our Experience in Minimizing the Risk of Pneumothorax.PLOS ONE

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4. Is the manuscript presented in an intelligible fashion and written in standard English?

PLOS ONE does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. Any typographical or grammatical errors should be corrected at revision, so please note any specific errors here.

Reviewer #1: Yes

Reviewer #2: Yes

**********

5. Review Comments to the Author

Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters)

Reviewer #1: An interesting manuscript in its field, I have no comments. This manuscript contains an interesting subject on the clinical field that any clinical doctor might encounter in the everyday clinical practice.

Reviewer #2: Overall, I think this is an interesting idea and potentially something to consider when placing SC lines. My main concern is that I am not convinced the measurements of the diameter were done accurately and consistently enough, and thus I am not sure of the validity of the results. I think it would be challenging for anyone to consistently measure the diameter of the vein in the same spot every time. I think a better description of how exactly these measurements were done and much better pictures would go a long way towards alleviating this concern. Additional specific comments and suggestions are given below.

Introduction

In general, I think there is a lot of superfluous information in the introduction that could be eliminated (such as the entire first paragraph). I would trim it down and just talk about why subclavian placement is done (advantages of this site over others) and then the purpose of your study.

here is complete unanimity regarding the value of central venous catheters in critically ill

patients. – I am not sure this statement is accurate and it is probably not needed. Consider modifying or deleting.

“Canulating the subclavian vein is part of everyday medical practice…” – I might be a relatively common procedure but I would not say it is part of everyday practice per se.

In terms of allowing for thrombotic events to be “abated” – perhaps it would be more accurate to say it lowers this risk as compared with the IJ or femoral sites

Rather than say the SC is preferred you might want to say “advantages of the SC site over the other options include…”

You might want to change the word fomenting to causing or something similar

Methodology

After 1 minute, the patients were safely placed in the Trendelenburg position. The

ultrasound probe would be placed parallel to the clavicle superiorly with slight acute angulation

towards the sternum, offering a coronal view – Could you include some images ?

It sounds like 1 sole operator performed all the procedures. Is that accurate?

Results

How was the SC vein diameter measured? Short or long axis? At the point of maximal diameter? Can you show an image with measurement ?

Figure 1 and 2 – please label x and y axis and please consider using different colors rather than different subtle shades of blue

What kind of ventilator was used?

Figure 3 is not very clear. The images of the vein look somewhat different in each view and it isn’t clear to me that diameter is really different because it looks like the measurement was not taken at exactly the same spot?

I think the main limitations concern how exactly the measurements were done, and possible lack of confidence that they were done the same way every time. It seems like it would be very easy to obtain different and conflicting results depending on how the measurements were done.

**********

6. PLOS authors have the option to publish the peer review history of their article (what does this mean?). If published, this will include your full peer review and any attached files.

If you choose “no”, your identity will remain anonymous but your review may still be made public.

Do you want your identity to be public for this peer review? For information about this choice, including consent withdrawal, please see our Privacy Policy.

Reviewer #1: No

Reviewer #2: No

**********

[NOTE: If reviewer comments were submitted as an attachment file, they will be attached to this email and accessible via the submission site. Please log into your account, locate the manuscript record, and check for the action link "View Attachments". If this link does not appear, there are no attachment files.]

While revising your submission, please upload your figure files to the Preflight Analysis and Conversion Engine (PACE) digital diagnostic tool, https://pacev2.apexcovantage.com/. PACE helps ensure that figures meet PLOS requirements. To use PACE, you must first register as a user. Registration is free. Then, login and navigate to the UPLOAD tab, where you will find detailed instructions on how to use the tool. If you encounter any issues or have any questions when using PACE, please email PLOS at figures@plos.org. Please note that Supporting Information files do not need this step.

PLoS One. 2023 Feb 2;18(2):e0281300. doi: 10.1371/journal.pone.0281300.r002

Author response to Decision Letter 0


19 Oct 2022

We are very grateful to you for providing us with the opportunity to submit a revised draft of our manuscript titled, “Title: Lung Deflation while Placing a Subclavian Vein Catheter: Our Experience in Minimizing the Risk of Pneumothorax” to Plos One. We are highly appreciative of the time and effort that have been dedicated to providing us with your valuable feedback on the manuscript. We are also thankful to the reviewers for their insightful comments. We have been able to incorporate changes to reflect most of the suggestions provided and have highlighted the changes accordingly in the manuscript.

Enclosed herewith is a point-by-point response to the reviewers’ comments and concerns.

Reviewer #1:

"An interesting manuscript in its field, I have no comments. This manuscript contains an interesting subject on the clinical field that any clinical doctor might encounter in the everyday clinical practice."

We are very grateful. The prospects of improving patient’s quality of care depend on repeated assessments of the measures taken. Therefore, this motivates us to explore unproven methods and validate the necessity to always question way to improve patients safety and outcome of care

Reviewer #2

"Overall, I think this is an interesting idea and potentially something to consider when placing SC lines. My main concern is that I am not convinced the measurements of the diameter were done accurately and consistently enough, and thus I am not sure of the validity of the results. I think it would be challenging for anyone to consistently measure the diameter of the vein in the same spot every time. I think a better description of how exactly these measurements were done and much better pictures would go a long way towards alleviating this concern. Additional specific comments and suggestions are given below."

Thank you very much for such an insightful comment. We do agree about the limitations caused due to the possible variability in measuring the diameter of the subclavian vein. To minimize the chance of error, We have chosen to have one operator for the whole patient group as the probe pressure and placement might differ from one person to the other. As enclosed in the supporting file attached in the submission, We have addressed the issue by showing one of the initial steps to defining the diameter used in our database which would be taking multiple measurements and choosing the greatest diameter. We believe that a single measurement used can account for the variability in ultrasound probe pressure compared to calculating cross sectional area. We do also agree about the lack of quality of imaging however we were unable to resolve the issue due to lack of modern ultrasound machines in the operating suite.

"In general, I think there is a lot of superfluous information in the introduction that could be eliminated (such as the entire first paragraph). I would trim it down and just talk about why subclavian placement is done (advantages of this site over others) and then the purpose of your study.

here is complete unanimity regarding the value of central venous catheters in critically ill

patients. – I am not sure this statement is accurate and it is probably not needed. Consider modifying or deleting.

“Canulating the subclavian vein is part of everyday medical practice…” – I might be a relatively common procedure but I would not say it is part of everyday practice per se.

In terms of allowing for thrombotic events to be “abated” – perhaps it would be more accurate to say it lowers this risk as compared with the IJ or femoral sites

Rather than say the SC is preferred you might want to say “advantages of the SC site over the other options include…”

You might want to change the word fomenting to causing or something similar"

"We highly appreciate your input. Accordingly we have made some changes to the introduction to make it shorter and with simpler, less sophisticated vocabulary.

After 1 minute, the patients were safely placed in the Trendelenburg position. The ultrasound probe would be placed parallel to the clavicle superiorly with slight acute angulation

towards the sternum, offering a coronal view – Could you include some images ?"

Thank you so much.

We have added a photo of a patient showing the ultrasound probe position against the patient’s clavicle as described

The photo has been labelled as “fig 1”

"it sounds like 1 sole operator performed all the procedures. Is that accurate?"

That is correct. The most senior anesthesia consultant performed all measurements and venipunctures on the patients. That was done to minimize the limitations due to lack of way to standardize the procedure in terms of complication rates, mispunctures and ultrasound placement

How was the SC vein diameter measured? Short or long axis? At the point of maximal diameter? Can you show an image with measurement

Multiple measurement were taken and the greatest of them has been recorded in the database. An image has been attached in the supplementary file labelled as fig S1

Figure 1 and 2 – please label x and y axis and please consider using different colors rather than different subtle shades of blue

Amendments to figure 2 and 3 ( previously labelled 1 and 2) have been made accordingly, thank you very much

What kind of ventilator was used?

GE Datex Ohmeda Avance S5 (Datex-Ohmeda, Ohmeda Drive, PO Box 7550, Madison, Wisconsin, 53707)

Figure 3 is not very clear. The images of the vein look somewhat different in each view and it isn’t clear to me that diameter is really different because it looks like the measurement was not taken at exactly the same spot?

We do agree, there are some variation in the images. We have noticed such variation in thin patients were chest expansion would greatly alter the ultrasound images. All the measurements would be recorded as the ultrasound is placed while the catheter is also being placed in the subclavian vein.

I think the main limitations concern how exactly the measurements were done, and possible lack of confidence that they were done the same way every time. It seems like it would be very easy to obtain different and conflicting results depending on how the measurements were done.

We are extremely grateful for your insightful comment.

We do agree there are some limitation to the methods used to measure the diameter of the subclavian vein however, we have made changes to the methodology while planning this study based on the limitation of previous studies to improve on the quality of evidence. Regardless, this warrants to need for further international collaborations and more prospective studies in favour of bettering patient safety and quality of care

Attachment

Submitted filename: Response to Reviewers.docx

Decision Letter 1

Eyüp Serhat Çalık

21 Nov 2022

PONE-D-22-12796R1Lung Deflation while Placing a Subclavian Vein Catheter: Our Experience in Minimizing the Risk of Pneumothorax.PLOS ONE

Dear Dr. Rabadi,

Thank you for submitting your manuscript to PLOS ONE. After careful consideration, we feel that it has merit but does not fully meet PLOS ONE’s publication criteria as it currently stands. Therefore, we invite you to submit a revised version of the manuscript that addresses the points raised during the review process. Reviewers' recommendations are below.

Please submit your revised manuscript by Jan 05 2023 11:59PM. If you will need more time than this to complete your revisions, please reply to this message or contact the journal office at plosone@plos.org. When you're ready to submit your revision, log on to https://www.editorialmanager.com/pone/ and select the 'Submissions Needing Revision' folder to locate your manuscript file.

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We look forward to receiving your revised manuscript.

Kind regards,

Eyüp Serhat Çalık

Academic Editor

PLOS ONE

Additional Editor Comments:

Dear Authors

I reviewed the original and R1 version of your article, the referee suggestions and your answers. First, I see that some of Reviewer 2's recommendations are not fully met. The resolution of the newly added 1st picture is good, but the picture gives the impression that it is not a real intubated patient picture, the sterile covers are very untidy. Please replace it with a higher quality and tidy image. Picture 4 looks the same, please add a new picture based on reviewer 2's suggestions.

In addition, I should say: Add more detailed subheadings in the material and method section. For example, your postprocedural protocol may be a sub-title and under this title you can define complications, the path you follow for diagnosis, etc. You can specify in more detail. You should also make a statistics subtitle and describe the statistical methods you use.

Make sure Reference 1 is written in the correct style.

Your article has been further reviewed by an additional reviewer. You should pay attention to Reviewer 3's recommendations, especially regarding updating references.

[Note: HTML markup is below. Please do not edit.]

Reviewers' comments:

Reviewer's Responses to Questions

Comments to the Author

1. If the authors have adequately addressed your comments raised in a previous round of review and you feel that this manuscript is now acceptable for publication, you may indicate that here to bypass the “Comments to the Author” section, enter your conflict of interest statement in the “Confidential to Editor” section, and submit your "Accept" recommendation.

Reviewer #1: All comments have been addressed

Reviewer #3: (No Response)

**********

2. Is the manuscript technically sound, and do the data support the conclusions?

The manuscript must describe a technically sound piece of scientific research with data that supports the conclusions. Experiments must have been conducted rigorously, with appropriate controls, replication, and sample sizes. The conclusions must be drawn appropriately based on the data presented.

Reviewer #1: Yes

Reviewer #3: Partly

**********

3. Has the statistical analysis been performed appropriately and rigorously?

Reviewer #1: N/A

Reviewer #3: Yes

**********

4. Have the authors made all data underlying the findings in their manuscript fully available?

The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception (please refer to the Data Availability Statement in the manuscript PDF file). The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data—e.g. participant privacy or use of data from a third party—those must be specified.

Reviewer #1: Yes

Reviewer #3: Yes

**********

5. Is the manuscript presented in an intelligible fashion and written in standard English?

PLOS ONE does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. Any typographical or grammatical errors should be corrected at revision, so please note any specific errors here.

Reviewer #1: Yes

Reviewer #3: Yes

**********

6. Review Comments to the Author

Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters)

Reviewer #1: An excellewnt manuscript in its field, I have no corrections

I agree with the results

Title: Lung Deflation while Placing a Subclavian Vein Catheter: Our Experience in

Minimizing the Risk of Pneumothorax. Purpose: Lung deflation may reduce the risk of

pneumothorax based on the assumption that the distance between the subclavian vein

and the lung pleura would increase as well as the diameter of the vein. We aim to

provide evidence to support the suggested desideratum of deflation in adults. Methods:

A prospective database was created that included patients who underwent subclavian

vein catheterization for monitoring and therapeutic reasons from January 2014 to

January 2020. Measurements using ultrasonography of the diameter of the subclavian

vein were taken while the patient's breathing was controlled by a ventilator and then

repeated after disconnecting the mechanical ventilation and opening the pressure relief

valve. Results: A total of 123 patients were enrolled, with an average age of 41.9

years. The subclavian vein diameter was measured during controlled breathing with a

mean average of 8.1 ± 0.6mm in males and 7.1 ± 0.5mm in females. The average

increase after lung deflation with the pressure relief valve closed was 8.0± 5.1mm in

males and 13.9 ± 5.4mm in females. An increase was noticed after opening a pressure

valve, and the means were 5.5 ± 2.8mm in males and 5.1 ± 3.3mm in females. The

catheter misplacement rate was 0.8% Conclusion: The benefit of interrupting

mechanical ventilation and lung deflation lies within possibly avoiding pneumothorax as

a complication of subclavian vein catheterization. These findings support the need for

evidence regarding the curtailment of pneumothorax incidence in spontaneously

breathing patients and the suggested increase in first-time punctures and success

rates.

Reviewer #3: PONE-D-22-12796R1

Thank you for providing an updated revision of your original manuscript - I was not a reviewer on the original submission, however I value the opportunity to provide further feedback to all authors.

This manuscript focuses on the use of active lung deflation to prevent pneumothorax during subclavian vein central catheter insertion.

While a novel concept of lung deflation has physiological actions, the benefits are purely focused on mechanically ventilated patient, of which the choice of catheter insertion site may be varied i.e use of IJV is not preferred when patient has a tracheostomy, had recent head/neck surgery or localized trauma in the area, etc..

Please ensure that page numbering is included with your submission, as this makes referencing to areas that require revision easier to pinpoint.

I have also read the previous reviewers comments of R0 and tend to agree somewhat with their points of discussion.

Considering the time-frame this work was performed (6 yrs), the numbers of devices placed was significantly low (n=123), averaging only 20.5 devices/year. This is considered under the minimal number to maintain a high standard of competency based upon published literature.

Was a powered study sample size calculated prior? A sample must be representative of the population, which this only included mechanically ventilated patients with selected inclusion criteria. How does this impact other patients who are critically ill or spontaneously breathing patients who may have a subclavian catheter placed also? Please consider this in your discussions.

Low sample sizes increase the margin of error into the analysis, potentially allowing for insufficient statistical power to answer the primary research question and creating a statistically non-significant result. The authors should clearly address this in the limitations sections of the manuscript.

ABSTRACT - satisfactory.

Please define ‘catheter misplacement’ in the manuscript - it is also mentioned in the abstract as 0.8% and should be described as a’ primary malposition’ as this is determined during the insertion phase. Please see https://doi.org/10.5301/JVA.2011.8381 which describes primary and secondary malpositions/misplacements.

KEYWORDS - please supply 6 keywords using MeSH terms whenever possible to improve searchability. Details can be found here - https://meshb.nlm.nih.gov/

MAIN -

Please try and use third-person perspectives throughout the entire paper when presenting your research e.g. (the authors, this study, these findings, etc.) rather than first-person (we, our, us, etc.) - this makes for a more academically prepared manuscript.

L67 - a femoral catheter tip does not have its tip located in the SVC/IVC as it is not a centrally located device. It would be most likely in the iliac vein at best, depending on total catheter length and patients body habitus. I would avoid stating that femoral catheters are centrally placed UNLESS these devices are over 45-50cm in length, which most traditional CVC’s are not. Correct nomenclature and terminology is important and standardization should be considered when making reference to correct device locations.

Please see the following publications for further details - https://doi.org/10.1177/11297298221126818

L69 - I don’t think its necessary to describe the Seldinger technique - it is already well known. Consider removing.

L73 - there is more recent evidence that supports the use of US guidance, with large number of systematic reviews - consider adding these, as Ref 4 is now a decade old

Suggested readings -

https://doi.org/10.2309/j.java.2019.004.002

https://doi.org/10.1016/j.jemermed.2020.07.039

https://doi.org/10.1007/s00134-019-05564-7

https://doi.org/10.1097/EJA.0000000000001383

https://doi.org/10.1177/0885066619868164

L73 - “Canulating the subclavian vein is part of common medical practice” - firstly, cannulating is spelt incorrectly, please correct.

Secondly, this is often not the case, as many trainees are most commonly taught the IJV approach first, which has been addressed in several publications. The subclavian approach has historically been a ‘high risk approach” however US has improved access to the vessel and actually increased the use of the Axillary vein, which has a clearer approach and visualization when using US. Consider this in your discussion also.

https://doi.org/10.1177/1129729819882602

https://doi.org/10.1007/s00134-019-05651-9

https://doi.org/10.1111/anae.15525

https://doi.org/10.1111/anae.15534

https://doi.org/10.1186/s13613-022-01065-x

https://doi.org/10.1186/s12871-021-01460-0

https://doi.org/10.7759/cureus.23823

https://doi.org/10.1177/11297298211038452

https://doi.org/10.3390/diagnostics12010049

Please create a LIMITATIONS section - while this is addressed at the end of the discussion, it should have its own section.

REFERENCES

17/20 (85%) greater than 4 yrs old. Many of these papers describe practices that are no longer current in today's standards of practice. I would seriously consider updating many of these citations to align with current practices. I have listed a number of quality papers previously that you can consider with your revisions.

FIGURES & TABLES

I would like to see some of the results tabulated for easy reading - currently, they are described in the results section, however the graphs do not do the results justice, making it harder to interpret. Please consider this in your future revisions.

Please ensure all figures have associated text to describe what is portrayed in the image.

Please provide a higher resolution image of Fig’s 2 & 3 - they are difficult to read and they also need a description associated with them. Please correct.

**********

7. PLOS authors have the option to publish the peer review history of their article (what does this mean?). If published, this will include your full peer review and any attached files.

If you choose “no”, your identity will remain anonymous but your review may still be made public.

Do you want your identity to be public for this peer review? For information about this choice, including consent withdrawal, please see our Privacy Policy.

Reviewer #1: Yes: paul zarogoulidis

Reviewer #3: No

**********

[NOTE: If reviewer comments were submitted as an attachment file, they will be attached to this email and accessible via the submission site. Please log into your account, locate the manuscript record, and check for the action link "View Attachments". If this link does not appear, there are no attachment files.]

While revising your submission, please upload your figure files to the Preflight Analysis and Conversion Engine (PACE) digital diagnostic tool, https://pacev2.apexcovantage.com/. PACE helps ensure that figures meet PLOS requirements. To use PACE, you must first register as a user. Registration is free. Then, login and navigate to the UPLOAD tab, where you will find detailed instructions on how to use the tool. If you encounter any issues or have any questions when using PACE, please email PLOS at figures@plos.org. Please note that Supporting Information files do not need this step.

PLoS One. 2023 Feb 2;18(2):e0281300. doi: 10.1371/journal.pone.0281300.r004

Author response to Decision Letter 1


7 Jan 2023

Prof. Emily Chenette

Editor-In-Chief

PLOS ONE

We are very grateful to you for providing us with the opportunity to submit a revised draft of our manuscript titled, “Title: Lung Deflation while Placing a Subclavian Vein Catheter: Our Experience in Minimizing the Risk of Pneumothorax” to Plos One. We are highly appreciative of the time and effort that have been dedicated to providing us with your valuable feedback on the manuscript. We are also thankful to the reviewers for their insightful comments. We have been able to incorporate changes to reflect most of the suggestions provided and have highlighted the changes accordingly in the manuscript.

Enclosed herewith is a point-by-point response to the reviewers’ comments and concerns.

Comments Reply

Reviewer #1:

An excellent manuscript in its field, I have no corrections

I agree with the results Thank you very much. The prospects of improving patient’s quality of care depend on repeated assessments of the measures taken. Therefore, this motivates us to explore unproven methods and validate the necessity to always question way to improve patients safety and outcome of care especially those who critically need it

Reviewer #2

Considering the time-frame this work was performed (6 yrs), the numbers of devices placed was significantly low (n=123), averaging only 20.5 devices/year. This is considered under the minimal number to maintain a high standard of competency based upon published literature.

Was a powered study sample size calculated prior? A sample must be representative of the population, which this only included mechanically ventilated patients with selected inclusion criteria. How does this impact other patients who are critically ill or spontaneously breathing patients who may have a subclavian catheter placed also? Please consider this in your discussions.

Low sample sizes increase the margin of error into the analysis, potentially allowing for insufficient statistical power to answer the primary research question and creating a statistically non-significant result. The authors should clearly address this in the limitations sections of the manuscript. Thank you very much for such an insightful comment.

We do agree and there are multiple factors that lead to the low patient numbers. The power indeed calculated during the initial phase of study design. In order for us to achieve 80% power with an alpha rate of 0.05 we needed 141 patients and our initial target was assigned to minimize the rate of type II error to its lowest rate possible.

However our initial study designed changed due to a significant difference in experience and complication rates per operator which would be a very important factor to eliminate as it is a major limitation to the validity of the anatomical significance this study provides. Having a single sole operator for the study limits the patient recruitment sample available for the study. To add, a significant number of patients have within our recruitment pool have not consented for the procedure and therefore the authors collectively agreed to analyze and publish the data with plans for multicentric international external validations

ABSTRACT - satisfactory.

Please define ‘catheter misplacement’ in the manuscript - it is also mentioned in the abstract as 0.8% and should be described as a’ primary malposition’ as this is determined during the insertion phase. Please see https://doi.org/10.5301/JVA.2011.8381 which describes primary and secondary malpositions/misplacements.

We highly appreciate your input.

The study protocol defined catheter malposition as a catheter that rests outsides the subclavian vein and the tip is not in its ideal position

The manuscript text has been edited accordingly as “misplacement” is an English technically vocabulary error.

KEYWORDS - please supply 6 keywords using MeSH terms whenever possible to improve searchability. Details can be found here - https://meshb.nlm.nih.gov/

Thank you so much.

The Keywords have been double check and are infact mesh indexed

Please try and use third-person perspectives throughout the entire paper when presenting your research e.g. (the authors, this study, these findings, etc.) rather than first-person (we, our, us, etc.) - this makes for a more academically prepared manuscript. We are highly thankful for your input and the text has been edited accordingly

a femoral catheter tip does not have its tip located in the SVC/IVC as it is not a centrally located device. It would be most likely in the iliac vein at best, depending on total catheter length and patients body habitus. I would avoid stating that femoral catheters are centrally placed UNLESS these devices are over 45-50cm in length, which most traditional CVC’s are not. Correct nomenclature and terminology is important and standardization should be considered when making reference to correct device locations.

Please see the following publications for further details - https://doi.org/10.1177/11297298221126818 The manuscript text has been edited accordingly

I don’t think its necessary to describe the Seldinger technique - it is already well known. Consider removing Thank you so much the manuscript has been edited accordingly

there is more recent evidence that supports the use of US guidance, with large number of systematic reviews - consider adding these, as Ref 4 is now a decade old

Suggested readings -

https://doi.org/10.2309/j.java.2019.004.002

https://doi.org/10.1016/j.jemermed.2020.07.039

https://doi.org/10.1007/s00134-019-05564-7

https://doi.org/10.1097/EJA.0000000000001383

https://doi.org/10.1177/0885066619868164

Canulating the subclavian vein is part of comm

on medical practice” - firstly, cannulating is spelt incorrectly, please correct.

Secondly, this is often not the case, as many trainees are most commonly taught the IJV approach first, which has been addressed in several publications. The subclavian approach has historically been a ‘high risk approach” however US has improved access to the vessel and actually increased the use of the Axillary vein, which has a clearer approach and visualization when using US. Consider this in your discussion also.

https://doi.org/10.1177/1129729819882602

https://doi.org/10.1007/s00134-019-05651-9

https://doi.org/10.1111/anae.15525

https://doi.org/10.1111/anae.15534

https://doi.org/10.1186/s13613-022-01065-x

https://doi.org/10.1186/s12871-021-01460-0

https://doi.org/10.7759/cureus.23823

https://doi.org/10.1177/11297298211038452

https://doi.org/10.3390/diagnostics12010049

REFERENCES

17/20 (85%) greater than 4 yrs old. Many of these papers describe practices that are no longer current in today's standards of practice. I would seriously consider updating many of these citations to align with current practices. I have listed a number of quality papers previously that you can consider with your revisions. Thank you so much for your input and we highly appreciate your efforts

We do agree and we have made amendments to the manuscript text however

There are some articles that quite critical as the evidence regarding anatomical and procedural maneuvers are quite limited.

The references list has been updated and corrected accordingly as well. Thank

Please create a LIMITATIONS section - while this is addressed at the end of the discussion, it should have its own section. Thank you so much and this has been done accordingly

FIGURES & TABLES

I would like to see some of the results tabulated for easy reading - currently, they are described in the results section, however the graphs do not do the results justice, making it harder to interpret. Please consider this in your future revisions.

Please ensure all figures have associated text to describe what is portrayed in the image.

Please provide a higher resolution image of Fig’s 2 & 3 - they are difficult to read and they also need a description associated with them. Please correct. We highly value your input and therefore the figures have been amended and improved as well

Thank you

Attachment

Submitted filename: Response to Reviewers.docx

Decision Letter 2

Eyüp Serhat Çalık

16 Jan 2023

PONE-D-22-12796R2Lung Deflation while Placing a Subclavian Vein Catheter: Our Experience in Minimizing the Risk of Pneumothorax.PLOS ONE

Dear Dr. Rabadi,

Thank you for submitting your manuscript to PLOS ONE. After careful consideration, we feel that it has merit but does not fully meet PLOS ONE’s publication criteria as it currently stands. Therefore, we invite you to submit a revised version of the manuscript that addresses the points raised during the review process. I have reviewed the R2 version of the manuscript and the responses to the reviewers' criticisms. There are a few minor issues that need to be corrected in the manuscript:

1- Paragraph 1, 2nd and 3rd sentences of the introduction section should be reorganized (lines 65-68), after the change the meaning of the sentences is distorted. 

2- You still have not defined the statistical methods you use in the statistics section (Chi-square test, Fisher's Exact Test, etc.).

3- The resolution of Figure 4 is still very bad, is there any chance to fix it?

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PLOS ONE

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PLoS One. 2023 Feb 2;18(2):e0281300. doi: 10.1371/journal.pone.0281300.r006

Author response to Decision Letter 2


18 Jan 2023

Paragraph 1, 2nd and 3rd sentences of the introduction section should be reorganized (lines 65-68), after the change the meaning of the sentences is distorted. Thank you so much for point the issue out and do acknowledge that it was unclear.

Alterations to sentences have been

You still have not defined the statistical methods you use in the statistics section (Chi-square test, Fisher's Exact Test, etc.). We highly appreciate your input and we have described the statistical test used to compare the average means

The resolution of Figure 4 is still very bad, is there any chance to fix it? Thank you so much.

We have reproduced the image and focused on minimizing the quality loss while collaging the pictures together. To ensure we provide the best quality we have also PACE ensure the picture meets the journal

Attachment

Submitted filename: Response to Reviewers.docx

Decision Letter 3

Eyüp Serhat Çalık

20 Jan 2023

Lung Deflation while Placing a Subclavian Vein Catheter: Our Experience in Minimizing the Risk of Pneumothorax.

PONE-D-22-12796R3

Dear Dr. Rabadi,

We’re pleased to inform you that your manuscript has been judged scientifically suitable for publication and will be formally accepted for publication once it meets all outstanding technical requirements.

Within one week, you’ll receive an e-mail detailing the required amendments. When these have been addressed, you’ll receive a formal acceptance letter and your manuscript will be scheduled for publication.

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Kind regards,

Eyüp Serhat Çalık

Academic Editor

PLOS ONE

Additional Editor Comments (optional):

Reviewers' comments:

Acceptance letter

Eyüp Serhat Çalık

24 Jan 2023

PONE-D-22-12796R3

Lung Deflation while Placing a Subclavian Vein Catheter: Our Experience in Minimizing the Risk of Pneumothorax.

Dear Dr. Rabadi:

I'm pleased to inform you that your manuscript has been deemed suitable for publication in PLOS ONE. Congratulations! Your manuscript is now with our production department.

If your institution or institutions have a press office, please let them know about your upcoming paper now to help maximize its impact. If they'll be preparing press materials, please inform our press team within the next 48 hours. Your manuscript will remain under strict press embargo until 2 pm Eastern Time on the date of publication. For more information please contact onepress@plos.org.

If we can help with anything else, please email us at plosone@plos.org.

Thank you for submitting your work to PLOS ONE and supporting open access.

Kind regards,

PLOS ONE Editorial Office Staff

on behalf of

Dr. Eyüp Serhat Çalık

Academic Editor

PLOS ONE

Associated Data

    This section collects any data citations, data availability statements, or supplementary materials included in this article.

    Supplementary Materials

    Attachment

    Submitted filename: Response to Reviewers.docx

    Attachment

    Submitted filename: Response to Reviewers.docx

    Attachment

    Submitted filename: Response to Reviewers.docx

    Data Availability Statement

    The dataset is not available publicly according to Institutional Review Board (IRB) decision (decision reference number: 15-2011) however it can accessed after obtaining the approval of the ethics committee at King Abdullah University Hospital and Jordan University of Science & Technology by contacting the following email: IRB@just.edu.jo.


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